Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
What we offer:
The Regulatory Business Operations Division is currently looking for a Regulatory Submission Manager :
Accountable for planning and execution of the dossier for product(s):
- Lead the dossier preparation and compilation, coordinate and manage the interaction with the different stakeholders.
- Responsible for the filing in due dates
Accountable for leading regulatory submission activities covering whole product lifecycle (from FIH to license withdrawal)
- Member of the Global regulatory Team, coordinating all activities relating to management of submission
- Support GRL while building submission plan and annual regulatory roadmap. Responsible for generating and follow-up of the timetables. Provide dashboard for steering the regulatory activity to the GRL and Global Regulatory Team
- Responsible for the coordination of pre-submission activities (CTA, IND dossiers)
- Responsible for the coordination of initial submissions (M1 to M5) in EU and US
- Responsible for compiling the reference dossier (M2 to M5) in close collaboration with the GRL and Regulatory CMC: producing e-CTD backbone structure of the reference dossier, and identifying owners and timing for each deliverable,
- Responsible for the planning of the dossier preparation WW on the basis of reference dossier, in close collaboration with RRL/local regulatory managers who provide the local requirements and adapt the TOC of the core dossier
Manage the dossier preparation and follow the submission
- Responsible for dossier building:
- Creating detailed Submission plan in MS Project for EU, US and Rest of the world
- Creating table of content based on reference dossier and local requirements provided by Regional Regulatory leads
- Setting up dossier according to the local TOC, consolidate specific local format/technical requirements
- Coordinate the collection of the documents related to the dossier preparation for submission (e.g. integrate CMC part to the dossier…)
- Liaise with publishing service provider for dispatch to markets and informs regional leads and GRL
- Ensure the follow up of the dispatch and submission with the support of the external vendor and LRA if applicable
- Responsible for updating dossier and core reference according to identified needs (e.g. new data, new requirements, questions for Agencies)
- Oversight of the regulatory databases. Define and trigger QC and monitoring action in collaboration with System Business Expert. Follow CAPA.
KPI responsibilities and interactions
- Meeting pre-agreed submission milestones for products, the submission manager coordinates or flagging as early as possible when he becomes aware of slipping timelines
- Is member of the Global Regulatory Team
• Key interfaces outside WRA: Medical Writing, TA and R&D Operations, TxM, Clinical development, Industry